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Assessment of As Needed Use of Pharmacotherapy and the Pause-Squeeze Technique in Premature Ejaculation

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Assessment of As Needed Use of Pharmacotherapy and the Pause-Squeeze Technique in Premature Ejaculation International Journal of Impotence Research (2001) 13, 41±45 ß 2001 Nature Publishing Group All rights reserved 0955-9930/01 $15.00 www.nature.com/ijir Assessment of as needed use of pharmacotherapy and the pause-squeeze technique in premature ejaculation IA Abdel-Hamid1*, EA El Naggar2 and A-H El Gilany3 1Department of Andrology, Mansoura Faculty of Medicine, Mansoura, Egypt; 2Department of Psychiatry, Mansoura Faculty of Medicine, Mansoura, Egypt; and 3Department of Community Medicine, Mansoura Faculty of Medicine, Mansoura, Egypt The objective was to compare the ef®cacy and safety of the as needed use of clomipramine, sertraline, paroxetine, sildena®l and the pause-squeeze technique in treatment of primary premature ejaculation. A prospective double blind randomized crossover study involving 31 patients was performed. Treatment phases comprised ®ve 4-week consecutive treatment periods, each separated by a two-week washout period. Patients were randomly assigned to receive each of the 4 drugs and use pause-squeeze on an as needed basis. Drugs were administered 3 to 5 hours before anticipated coitus. Anxiety score and ejaculation latency time were measured before treatment, after each treatment, and during washout periods. Sexual satisfaction score was measured after each treatment. The median ejaculation latency time was signi®cantly increased from the pretreatment median of 1 minute to 4 minutes, 3 minutes, 4 minutes, 15 minutes and 3 minutes during treatment with clomipramine, sertraline, paroxetine, sildena®l and pause-squeeze technique, respectively (all P 0.0001). Sildena®l was superior to other modalities in terms of ejaculation latency and satisfaction (P 0.0001). The three antidepressants were comparable to each other in terms of ef®cacy (P > 0.05). Paroxetine was superior to the pause-squeeze technique in terms of ef®cacy (P < 0.05). In conclusion, sildena®l appears to be superior to other modalities and a valid alternative in treatment of premature ejaculation. The 3 antidepressants were equivalent to each other in terms of ef®cacy and safety. Paroxetine was superior to pause-squeeze technique in terms of ef®cacy. International Journal of Impotence Research (2001) 13, 41±45. Keywords: premature ejaculation; behavioral therapy; antidepressants; sildena®l Introduction documented the success of this modality when used as needed in the treatment of premature ejacula- tion.2,10 Recent knowledge has been gained with Premature ejaculation has been treated with various oral sildena®l treatment of psychogenic impotence. modalities. These modalities include behavioral Sildena®l is a potent and selective inhibitor of cyclic therapy,1,2 topical applications,3 oral pharmacother- guanosine monophosphate (cGMP)-speci®c phos- apy,4±6 and intracavernosal vasoactive drug injec- phodiesterase type 5. It thus enhances the relaxant tion.7 Oral pharmacotherapy such as the tricyclic effect of nitric oxide released in response to sexual antidepressant, clomipramine, and serotonin re- stimulation by increasing cGMP concentrations in uptake inhibitors, are associated with variable rates the corporal smooth muscle.11 Since premature of success when taken daily.5,8 In contrast some ejaculation, like psychogenic impotence, is a per- reports suggest that these drugs may be effective formance-anxiety problem in an otherwise normal when received as needed.4,9 Although behavioral male, it could be anticipated that oral sildena®l therapy requires partner cooperation, some reports would work in the treatment of premature ejacula- tion. Since the comparison of these different modalities when used as needed has not been evaluated, this study was undertaken to compare *Correspondence: IA Abdel-Hamid, Department of the ef®cacy and safety of as needed use of oral Andrology, Mansoura Faculty of Medicine, PO Box 35516, Mansoura, Egypt. clomipramine, sertraline, paroxetine, sildena®l and E-mail: [email protected] the Masters and Johnson pause-squeeze technique Received 3 August 2000; accepted 9 September 2000 in the treatment of primary premature ejaculation. Pharmacotherapy and the pause-squeeze technique in premature ejaculation IA Abdel-Hamid et al 42 Methods satisfaction questionnaire (patient version) designed by Althof et al13 for measuring the degree of sexual satisfaction among erectile dysfunction patients. From May 1999 to June 2000, 31 heterosexual men We found that the ®rst 9 items are applicable to complaining of primary premature ejaculation from premature ejaculation. Higher scores indicate great- the beginning of their sexual life were enrolled in er satisfaction. This questionnaire was translated this study. Premature ejaculation was de®ned as into Arabic by two independent translators. All intravaginal ejaculation latency time (IVELT) of less measurements were obtained before treatment, after than 2 minutes and the patient complained of little, each treatment and after each washout period. if any, control over their ejaculation. The patients Twenty healthy men who reported a sexual history were recruited from the outpatient clinic of the free of symptoms of premature ejaculation acted as a andrology and sexology unit, Mansoura University control group. The control group was subjected to Hospital, Mansoura, Egypt. All patients gave their measurement of anxiety score. After the completion verbal consent to participate in the study. Inclusion of the study, the unblinded code revealed that 7 criteria include persons married for at least 1 y and patients began with clomipramine, 6 with sertraline, willingness to attempt sexual intercourse at least 6 with paroxetine, 6 with sildena®l and 6 patients twice per week with a cooperative female partner. began with the pause-squeeze technique. Exclusion criteria include the following: (a) history of a psychiatric disorder; (b) current physical illness (eg, diabetes, liver disease and so forth); (c) previous Statistical analysis surgery or drug known to affect sexual function; (d) current substance abuse (alcohol or drug); (e) patients with secondary premature ejaculation The variables in this study were statistically pro- combined with erectile dysfunction. All patients cessed using SPSS program for windows, standard were asked not to use condoms or topical penile version, release 8.0. The data were subjected to applications. Kolmogorov-Smirnov one sample test, to test for The study utilized a prospective randomized normal distribution. This test showed that all the double blind crossover design. Treatment phases outcome variables were nonparametric. Nonpara- comprised ®ve 4-week consecutive treatment peri- metric statistical tests were used to assess differ- ods, each separated by a two-week washout period. ences in the measurements. Friedman's two-way Each patient was informed that he would be treated analysis of variance was used for comparison with 5 different modalities of therapies of identical between all the treatment periods. Wilcoxon signed action to ascertain which of the 5 was most useful. rank test was used for evaluation of measures The patients were randomly assigned to receive between baseline and after each treatment and also clomipramine hydrochloride 25 mg (Anafranil1, between each two treatment periods. The relation- Novartispharma, Cairo, Egypt), sertraline hydro- ship between parameters was quanti®ed by using chloride 50 mg (Lustral1, P®zer, Cairo, Egypt), the Spearman rank correlation coef®cient. Chi- paroxetine hydrochloride 20 mg (Seroxat1, Smith- square and Fisher exact tests were used for compar- KlineBeecham pharmaceuticals, Brentford, Eng- ison of the incidence of side effects among different land), sildena®l citrate 50 mg (Viagra1, P®zer, New treatments. Student's t-test and Chi-square test were York, USA) and to use the pause-squeeze technique used for comparison between the study group and according Masters and Johnson.2 The drugs were control group. A two-tailed P-value < 0.05 was administered as needed 3 to 5 hours before planned considered signi®cant. intercourse and not more than twice a week. The pause-squeeze technique was used during inter- course. Each patient was randomly assigned to Results receive any of the available treatments as the ®rst treatment and a sequence of treatment regimens. The assignment was unknown by the patient or the Table 1 shows the baseline characteristics of the investigator. Subjects were asked to complete a patient and control groups. Of 31 patients, 25 questionnaire, which we designed, that contained (80.6%) completed the 5 treatment periods. The 6 items such as intravaginal ejaculation latency time patients who dropped out of the study used between of the last 2 consecutive experiences of intercourse, 1 and 4 modalities (mean 3). Reasons for dropout frequency of intercourse and possible side effects. included lack of ef®cacy (clomipramine 2, sertraline Intravaginal ejaculation latency time was measured 2, paroxetine 2 and the pause-squeeze technique 2), by the patient using a watch. Anxiety measurement side effects (sildena®l 2) and lack of ef®cacy plus was assessed using an Arabic questionnaire (0 ± 30 side effects (clomipramine 1). Before treatment the scores) designed by Shaheen and Elrakhawy12 with anxiety score was signi®cantly higher among pa- higher scores indicating greater anxiety. We used tients in comparison with the control group (Table the ®rst 9-items (0 ± 30 scores) of the sexual 1). After 4-week treatments with clomipramine, International Journal of Impotence Research Pharmacotherapy and the pause-squeeze technique in premature ejaculation IA Abdel-Hamid et al 43 Table 1 Baseline characteristics of patients and control group signi®cant positive correlation (r 0.666, P 0.01) between anxiety score and IVELT during treatment Patients Control Signi®cance n 31 n 20 test P with the pause-squeeze technique. Moreover, we found signi®cant negative correlation between Age (y) anxiety score and sexual satisfaction score dur- Range 27 ± 42 25 ± 46 ing treatment with the pause-squeeze technique Mean Æ s.d. 34.09 Æ 4.29 34.8 Æ 6.44 t 0.47 0.54 Median 34.0 33.5 (r 70.547, P 0.01), clomipramine (r 70.381, Duration of marriage (y) P < 0.05), sildena®l (r 70.573, P 0.01).
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